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Commonly Asked Questions about Ema Application Forms

What is EMA submission?

The European Medicines Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. Under the European centralized procedure, companies submit a single marketing-authorization application to the European Medicines Agency (EMA). European Medicines Agency - an overview | ScienceDirect Topics ScienceDirect.com topics european-medic ScienceDirect.com topics european-medic

How long does it take for the EMA to approve a drug?

The assessment of a marketing authorisation application for a new medicine takes up to 210 active days. This active evaluation time is the time spent by EMA experts to evaluate the evidence provided by the applicant in support of a marketing authorisation application.

How and when should the eligibility request be sent to the EMA?

The eligibility request should be submitted 18 to 7 months before the planned MAA submission date and submitted to EMA 10 calendar days before the planned and published CHMP meeting date. Decision of eligibility is received in the week following CHMP meeting where the discussion took place.

What is EMA certificate?

The purpose of the European Medicines Agencys (EMA) certification scheme for human and veterinary medicines is to confirm the medicines marketing authorisation status and that it complies with good manufacturing practice (GMP) standards. Certification of medicinal products European Medicines Agency - European Union post-authorisation certific European Medicines Agency - European Union post-authorisation certific

How do I submit my Psur to EMA?

How do I submit a PSUR? All PSURs are submitted to EMAs PSUR repository using the eSubmission Gateway/ Web Client: . The required submission format is eCTD (mandatory for all centrally authorised products) or non-eCTD electronic submission (NeeS).

How do I submit my scientific advice to EMA?

Apply using the IRIS platform Scientific advice applicants need to upload a draft briefing document introducing the medicine under development and the applicants questions and positions in IRIS at the time of applying. It is mandatory to use the CHMP scientific advice/protocol assistance briefing document template.

How do I submit an EMA?

Submission of the application Applicants should use the electronic common technical document (eCTD) format and submit the application through the eSubmission gateway or web client . If EMA needs additional information to complete its validation of the application, it will ask the applicant to supply this by a deadline. Obtaining an EU marketing authorisation, step-by-step European Medicines Agency - European Union human-regulatory-overview European Medicines Agency - European Union human-regulatory-overview